Tiotropium Bromide Alone vs Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD (Study P04272) (COMPLETED)
This study has been completed.
Integrated Therapeutics Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: August 30, 2005
Last updated: February 20, 2014
Last verified: February 2014
This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients with COPD.
Pulmonary Disease, Chronic Obstructive
Drug: formoterol fumarate
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||A Double-Blind Randomized, Parallel-Group, Multicenter Clinical Study to Compare the Efficacy and Tolerability of Tiotropium Bromide Alone vs. the Co-Administration of Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2006 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||40 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subjects must have a clinical history of COPD.
- Subjects must be current cigarette smokers or ex-smokers who stopped smoking at least 3 months prior to screening visit (V1). Subjects must have a smoking history of at least 10 pack-years (20 cigarettes per pack). Pack-years are calculated by multiplying the average packs of cigarettes smoked per day times the number of years.
- Subjects on stable inhaled corticosteroids are allowed to be enrolled and to remain on the treatment throughout the study.
- Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules.
- Subjects must agree to inform their usual treating physician of their participation in this study.
- Female subjects of childbearing potential must have a negative urine pregnancy test prior to the randomization of the study
- Nonpregnant women of childbearing potential must be using a medically acceptable, adequate form of birth control.
- Subjects have a current or past history of clinically relevant asthma.
- Subjects quit smoking less than 3 months prior to the Screening visit (V1).
- Subjects have required ventilator support for respiratory failure within the last year.
- Subjects have clinically significant lung disease other than COPD, e.g., bronchiectasis, sarcoidosis, pulmonary fibrosis, tuberculosis, etc.
- Subjects have undergone lobectomy, pneumonectomy or lung volume reduction surgery.
- Subjects have had lung cancer diagnosed or treated within the last five years.
- Subjects require nasal continuous positive airway pressure (CPAP) or bi-level positive airway pressure (Bi-PAP).
- Subjects have initiated pulmonary rehabilitation within the past 3 months.
- Subjects use oxygen >= 2 liters per minute for > 2 hours per day.
- Subjects require chronic or prophylactic treatment with antibiotics.
- Subjects have significant renal, hepatic, cardiovascular (including cor pulmonale), metabolic, neurologic, hematologic, gastrointestinal, cerebrovascular or other significant medical illness or disorder which, in the judgment of the Investigator, may interfere with the study or require treatment which may affect the evaluation of efficacy and safety of the study drug.
- Subjects have clinically significant abnormalities on chest x-ray (other than evidence of COPD) at the Screening visit or within the previous year.
- Women are pregnant or breast-feeding.
- Subjects cannot adhere to the concomitant medications restrictions and prohibitions.
- Subjects have used any investigational product within 30 days, or 3 months for any biologic of unknown half-life, prior to the Baseline Visit (V3).
- Subjects are part of the staff or a family member of the staff personnel directly involved with this study.
- Subjects have chronic narrow-angle glaucoma.
- Subjects have symptomatic prostatic hyperplasia or bladder-neck obstruction.
No Contacts or Locations Provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 30, 2005
||February 20, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Central Nervous System Agents
Adrenergic beta-2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Peripheral Nervous System Agents
Respiratory System Agents